K091594 · Ge Medical Systems Information Technologies GmbH · MHX · Jul 29, 2009 · Cardiovascular
Device Facts
Record ID
K091594
Device Name
HEART-EXERCISE
Applicant
Ge Medical Systems Information Technologies GmbH
Product Code
MHX · Cardiovascular
Decision Date
Jul 29, 2009
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.1025
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The HEART-Exercise is to be used in a hospital, doctor's office, or clinical environment by competent healthcare professionals for assessing exercise test results. The results of HEART-Exercise are intended to be used by qualified personnel in evaluating the patient in conjunction with the patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment. HEART-Exercise provides measurements, prognostic scores, and interpretive statements of the exercise test for which the physician renders his/her own opinion. HEART-Exercise does not offer a diagnostic opinion to the user. The Exercise Test Interpretation (XTI) is restricted to adults (age ≥ 18 years). The measurements apply to adults and children able to accomplish an exercise test.
Device Story
HEART-Exercise is an algorithm library for exercise testing systems; processes up to 15-lead ECG signals with high noise/artifact levels. Provides real-time and retrospective computerized analysis of stress test ECGs. Used in hospitals, clinics, or doctor's offices by healthcare professionals. Outputs include measurements, prognostic scores, and interpretive statements. Clinicians use these outputs alongside patient history, symptoms, and other diagnostic tests to render clinical opinions. Device does not provide diagnostic opinions. Benefits include standardized, automated analysis of exercise ECG data to assist professional clinical judgment.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical testing, including risk analysis, requirements/design reviews, module verification, and final acceptance testing.
Technological Characteristics
Algorithm library for exercise testing systems; processes up to 15-lead ECGs. Software-based analysis of stress test ECGs. Complies with voluntary standards for quality assurance and performance testing.
Indications for Use
Indicated for use in hospital, doctor's office, or clinical settings by healthcare professionals to assess exercise test results in patients. Exercise Test Interpretation (XTI) restricted to adults (age ≥ 18 years); measurements applicable to adults and children capable of performing an exercise test.
Regulatory Classification
Identification
The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
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JUL 2 9 2009
# GE Healthcare
510(k) Premarket Notification Submission
#### 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: May 29, 2009
Submitter: GE Healthcare, GE Medical Systems Information Technologies GmbH Munzinger Str. 3 79111 Freiburg, Germany
Primary Contact Person:
Patricia Taige Requlatory Affairs - Diagnostic Cardiology GE Healthcare, GE Medical Systems Information Technologies 9900 Innovation Drive Wauwatosa, WI 53226 Phone: (414) 721-3222 Fax: (414) 721-3863
Secondary Contact
Person:
RA Director - Patient Monitoring
GE Healthcare, GE Medical Systems Information Technologies 8200 West Tower Avenue
Milwaukee, WI 53223 Phone: (262) 510-9997
Fax: (414) 918-8112
David Wahlig
Trade Name: HEART-Exercise
ECG Analysis Computer, Programmable Diagnostic Computer
Classification Names: 21 CFR 870.1425 Product Code: DOK
Intended Use:
Predicate Device(s): Device Description:
Common/Usual Name:
Device:
CardioSoft/CASE Cardiac Testing System (K031561)
HEART-Exercise is an algorithm library for exercise testina systems. It is able to process up to 15 lead ECGs with a high noise and artifact level and provides real-time and retrospective computerized analysis of stress test ECGs for evaluation by the user.
The HEART-Exercise is to be used in a hospital, doctor's office, or clinical environment by competent healthcare professionals for assessing exercise test results.
The results of HEART-Exercise are intended to be used by
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## (091594 キ2/2 GE Healthcare
510(k) Premarket Notification Submission
qualified personnel in evaluating the patient in conjunction with the patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment.
HEART-Exercise provides measurements, prognostic scores, and interpretive statements of the exercise test for which the physician renders his/her own opinion. HEART-Exercise does not offer a diagnostic opinion to the user.
The Exercise Test Interpretation (XTI) is restricted to adults (age ≥ 18 years). The measurements apply to adults and children able to accomplish an exercise test
The proposed HEART-Exercise algorithm library employs the same fundamental scientific technology as the HEART-Exercise algorithm library currently cleared as part of the predicate device CardioSoft/CASE Cardiac Testing System (K031561)
Summary of Non-Clinical Tests: Determination of
> The HEART-Exercise algorithm library and its applications comply with voluntary standards as detailed in Section 9 and 16 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Final acceptance testing (Validation)
- Performance testing (Verification)
#### Summary of Clinical Tests:
The subject of this premarket submission, HEART-Exercise, did not require clinical studies to support substantial equivalence.
Conclusion:
Technology:
Substantial Equivalence:
GE Healthcare considers the HEART-Exercise algorithm library to be as safe, as effective, and performance is substantially equivalent to the predicate device.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
## JUL 29 2009
GE Healthcare, GE Medical Systems Information Technologies GmbH c/o Ms. Patricia Taige Regulatory Affairs - Diagnostic Cardiology 9900 Innovation Drive Wauwatosa, WI 53226
K091594 Re:
HEART - Exercise
Regulation Number: 21 CFR 870.1025
Regulation Name: Arrhytmia detector and alarm (including ST- segment measurement and alarm)
Regulatory Class: Class II (two) Product Code: MHX, (DQK, DXH, DPS) Dated: May 29, 2009 Received: June 02, 2009
Dear Ms. Taige: .
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general confrols provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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### Page 2 - Ms. Patricia Taige
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K09/594
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## GE Healthcare
510(k) Premarket Notification Submission
510(k) Number (if known):
HEART-Exercise Device Name:
Indications for Use:
The HEART-Exercise is to be used in a hospital, doctor's office, or clinical environment by competent healthcare professionals for assessing exercise test results.
The results of HEART-Exercise are intended to be used by qualified personnel in evaluating the patient in conjunction with the patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judament.
HEART-Exercise provides measurements, prognostic scores, and interpretive statements of the exercise test for which the physician renders his/her own opinion. HEART-Exercise does not offer a diaqnostic opinion to the user.
The Exercise Test Interpretation (XTI) is restricted to adults (age ≥ 18 years). The measurements apply to adults and children able to accomplish an exercise test.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21.CFR 801 Subpart C)
(Please do Not Write Below this Line - Continue on another Page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
B Zuckerman
7/29/09
Division of Cardiovascular Devices 1091594 510(k) Number
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Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
